Description
Our Client is a biotech company based in Waterford; they currently seek a Manager for the QTA group within the QC department. The QTA Manager has a primary role in the delivering the site analytical development and capability enhancement programs, with a core focus on New Product Introduction and Analytical and Equipment Lifecycle Management and Remediation.Accountabilities:
- Accountable for delivering method transfers, Development to Validation, Assessment and Remediation
- Establishes programs for New QC Technology evaluation and innovation.
- Accountable for QC capital program delivery, assessing and implementing the technologies to stay current with state of the art and industry best practices
- Accountable for delivering the analytical support of the NPI process.
- Accountable for delivery of the site ALCM process
- Enables QTA to provide analytical testing and knowledge support to wider internal and external customers
- Manages team of QTA team leader(s), scientists, analysts and project managers to effectively deliver mandated programs
- Manage QTA spend to Opex and Capex budget
Qualifications
- Degree in Science (Chemistry, Microbiology or Pharmacy preferred)
- Post-graduate studies as appropriate to augment primary degree
Skills & Knowledge
- Detailed knowledge of Biopharma analytical methodologies and technologies.
- Effective technical knowledge of Biopharmaceutical manufacturing
- Knowledge of requirements for cGLP, cGMP, pharmacopoeial methods and stability.
- Ability to manage projects to plan/budget
- Excellent & efficient communicator at organisation, team and individual levels
- High energy, commitment and flexibility.
- Ability to work independently and adapt.
- Excellent leadership skills with ability to influence and affect change
- Capable of resolving issues of conflict effectively within a team
- Ability to understand the 'broader picture' and business context
- Ability and willingness to identify opportunities to 'break the mould' with systems and processes
Experience:
- +10 years in biopharma industry, with Operational experience of quality laboratories in a fast moving manufacturing environment and demonstrated project management experience.
- Experience of analytical transfer programs and method development/validation
- A proven track record in the ability to transfer goals and objectives into measurable plans.
- Management experience essential
If you are interested in this great opportunity and have the relevant skill set and experience please contact me Anna Mooney or apply below with a up to date CV.